Trial Outcomes & Findings for Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy (NCT NCT01535326)
NCT ID: NCT01535326
Last Updated: 2014-08-15
Results Overview
proportion of patients without insertion pain during colonoscopy
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
up to 12 months
Results posted on
2014-08-15
Participant Flow
Participant milestones
| Measure |
Air Insufflation
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
|
Water Immersion
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
|
Water Exchange
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
|
|---|---|---|---|
|
Overall Study
STARTED
|
90
|
90
|
90
|
|
Overall Study
COMPLETED
|
90
|
90
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Water Immersion and Water Exchange Methods During Minimally Sedated Colonoscopy
Baseline characteristics by cohort
| Measure |
Air Insufflation
n=90 Participants
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
|
Water Immersion
n=90 Participants
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
|
Water Exchange
n=90 Participants
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59 years
n=39 Participants
|
53 years
n=41 Participants
|
58 years
n=35 Participants
|
55 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=39 Participants
|
37 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
102 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
55 Participants
n=35 Participants
|
168 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsproportion of patients without insertion pain during colonoscopy
Outcome measures
| Measure |
Air Insufflation
n=90 Participants
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
Proportion of no pain: 30%
|
Water Immersion
n=90 Participants
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
Proportion of no pain: 43.3%
|
Water Exchange
n=90 Participants
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
Proportion of no pain: 61.1%
|
|---|---|---|---|
|
Proportion of Patients Without Pain
|
27 participants
|
39 participants
|
55 participants
|
SECONDARY outcome
Timeframe: 9 to 12 monthsThe maximal pain score during insertion phase of colonoscopy was assessed with 0 to 10 scale VAS score (0: no pain; 10: maximal pain)
Outcome measures
| Measure |
Air Insufflation
n=90 Participants
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
Proportion of no pain: 30%
|
Water Immersion
n=90 Participants
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
Proportion of no pain: 43.3%
|
Water Exchange
n=90 Participants
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
Proportion of no pain: 61.1%
|
|---|---|---|---|
|
Patient Pain Score
|
3.5 units on a scale
Interval 0.0 to 10.0
|
1.8 units on a scale
Interval 0.0 to 8.5
|
0 units on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: 9 to 12 monthssatisfaction score obtained after colonoscopy 0 = no satisfied; 10 = most satisfied
Outcome measures
| Measure |
Air Insufflation
n=90 Participants
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
Proportion of no pain: 30%
|
Water Immersion
n=90 Participants
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
Proportion of no pain: 43.3%
|
Water Exchange
n=90 Participants
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
Proportion of no pain: 61.1%
|
|---|---|---|---|
|
Patient Satisfaction Score
|
10 units on a scale
Interval 6.5 to 10.0
|
10 units on a scale
Interval 7.0 to 10.0
|
10 units on a scale
Interval 8.0 to 10.0
|
SECONDARY outcome
Timeframe: 9 to 12 monthsthe number of participants with at least one adenoma in each of the study groups.
Outcome measures
| Measure |
Air Insufflation
n=90 Participants
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
Proportion of no pain: 30%
|
Water Immersion
n=90 Participants
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
Proportion of no pain: 43.3%
|
Water Exchange
n=90 Participants
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
Proportion of no pain: 61.1%
|
|---|---|---|---|
|
Number of Participants With at Least One Adenoma
|
39 participants
|
41 participants
|
51 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: one monthtelephone follow up for post-procedure discomforts and 30 day complication rate
Outcome measures
Outcome data not reported
Adverse Events
Air Insufflation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water Immersion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Water Exchange
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Air Insufflation
n=90 participants at risk
Use air insufflation during colonoscopy
air insufflation: insufflate air during the insertion of colonoscopy
|
Water Immersion
n=90 participants at risk
infuse water during insertion, remove water during withdrawal of colonoscopy
water immersion: infuse water during insertion, aspirate water during withdrawal
|
Water Exchange
n=90 participants at risk
infuse and remove water during insertion phase of colonoscopy
water exchange: infuse and remove water during insertion phase of colonoscopy
|
|---|---|---|---|
|
Gastrointestinal disorders
perforation
|
0.00%
0/90
|
0.00%
0/90
|
1.1%
1/90 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place